Through our R&D and medical activities, Sanofi aims to constantly innovate in multiple therapeutic areas while meeting the highest ethical standards. Built on a sound governance system overseen by the Sanofi Bioethics Committee, our strategic approach is designed so that our standards and practices are continuously challenged in response to existing and emerging ethical considerations (for more information, refer to Sanofi Bioethics Framework).
We embed this approach in our practices to ensure the responsible use of resources and technologies in research and production and support ethical conduct in clinical development involving patients and healthy subjects.
When preclinical research has been shown to be successful, clinical trials will be conducted on humans. It is important to note that animals are only used in medical research when absolutely necessary and unavoidable – in situations where appropriate alternatives are not available (for more information refer to our Principles on Animal Protection).
Contribution to International Initiatives Promoting Good Practices
Sanofi is a member of several international organizations promoting good bioethics practices, including the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard University (MRCT) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
Sanofi also participates to specific European projects, such as FACILITATE, to contribute to the reflection on the return of clinical trial data to study participants and to provide, with others, the industry perspective.
Ethical Practices in Clinical Trials
For every clinical trial, Sanofi seeks to ensure:
- Patient safety according to the highest ethical standard: Sanofi applies international standards: the Declaration of Helsinki, the recommendations of the International Council for Harmonization (ICH), and in particular Good Clinical Practices (GCP). In addition to these international standards, Sanofi complies with all national and international rules and laws applicable to clinical trials including European Directives 2001/20/EC (on the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, published in Official Journal L 121 of May 1, 2001, page 34, as amended in 2006 and 2009) and 2005/28/EC (laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorization of the manufacturing or importation of such products, published in Official Journal L 91 of April 9, 2005, pages 13-19); the CFR21 regulations issued by the US Food and Drug Administration (FDA); and the regulations issued by the Japanese Ministry of Health, Labor and Welfare (MHLW).
- Transparency of medical and clinical data: Sanofi abides by the principles on the responsible sharing of clinical trial data adopted by Pharmaceutical Research and Manufacturers of America (PhRMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) members in July 2013. In addition to those core principles, we apply our own policy on sharing and transparency of clinical data. Our commitments are described (and fully accessible) on our corporate website.
- Representation in Clinical Trials: Sanofi adopted key principles to recognize the role and importance of appropriate representation in our clinical research programs.
Our Performance in 2025:
- Overview of clinical trial activity: 185 clinical trials were conducted by Sanofi: 146 managed by Pharma (13,004 subjects treated) and 39 managed by Vaccines (13,380 subjects treated).
- Internal inspections and audits:
- None of the 75 clinical inspections conducted on our clinical research activities resulted in regulatory action.
- Sanofi conducted 149 audits for our clinical trial activities (Pharma and Vaccines).
- Transparency of medical and clinical data:
- As of Dec 31, 2025, Sanofi received a total of 396 requests that included 871 clinical studies. 48 requests were received in 2025
- Data was shared from 260 clinical trials in 2025:
- Data from these trials have been, are currently, or will be used in active research projects and have resulted in 79 publications in 2025.
- 546 clinical trial data sharing requests were not approved, according to Sanofi's data sharing policy. Reasons to exclude these trials from the data sharing program include Sanofi not having the legal right to share the data, patient privacy cannot be adequately protected, and the requested data are out of scope.
- Scientific papers published: 807 scientific and medical papers sponsored or signed by Sanofi were included in the PubMed database, which references over 5,200 journals
- Access to products: Sanofi approved 77% of requests for access to products through Managed Access Programs in 2025.
In 2024, we launched the Sanofi Patient Promise to further strengthen our engagement with patient organizations. It was developed in collaboration with patients, caregivers, and advocacy organizations, and we will continue to consult, involve, and work with these communities as we deliver on this Promise and its commitments. For more information, see Sanofi Patient Community Promise. In 2025, we published our first Patient Engagement report that reflects on the effectiveness of our engagement activities. Through ongoing dialogue, we are deepening our commitment to patients to better understand and serve their needs.